Status:
COMPLETED
Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Ureteral Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period. Patients usually treate...
Detailed Description
Introduction: The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J...
Eligibility Criteria
Inclusion
- Age 18-year-old or superior
- Chronic stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
- No possibility for surgical or endoscopic treatment of the ureteral stricture
- Free Consent, dated and signed by the patient
- Affiliated Subject of a regime of French national health and pensions organization.
Exclusion
- Age under 18 year old
- Pregnant or nursing Women
- Patient having a life expectancy of less than 1 year
- Patient having unique kidney
- Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
- Possible surgical or endoscopic treatment of ureteral stricture
- Repeated urinary tract stones
- Urothelial tumor of the bladder
- Retro peritoneal fibrosis in the course of evolution
- Complications of double J stents requiring more thanks a lot every 6 months
- Against anaesthetic indication
- Lithiasic inlay probe Double J with obstruction within 6 months
- Persons put under maintenance of justice
- Persons in inability to understand the sequence of try
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00790686
Start Date
November 1 2008
End Date
May 1 2013
Last Update
August 21 2014
Active Locations (4)
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1
Department of Urology, University Hospital, Bordeaux
Bordeaux, France, 22076
2
Department of Urology, University Hospital, Limoges
Limoges, France, 87042
3
Department of Urology, Hospices Civils de Lyon
Lyon, France, 69437
4
Department of Urology, University Hospital, Toulouse
Toulouse, France, 31059